This two-part article focuses on risk management of facilities and equipment. It describes how a risk-based approach to facilities and equipment management fits into an integrated, effective quality systems structure. The principles discussed are equally applicable to all quality systems. Facilities and equipment represent a broad range of risk to product quality and are one of the key quality systems commonly identified in the pharmaceutical manufacturing industry. Continue reading
#198 – RISK MANAGEMENT … THE WHAT, WHY, AND HOW – MICHAEL STANLEIGH
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Risk Management is the process of identifying, analyzing and responding to risk factors throughout the life of a project and in the best interests of its objectives. Proper risk management implies control of possible future events and is proactive rather than reactive. Continue reading
#198 – SEARCHING FOR ZERO – ROBERT POJASEK
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In the 1990’s, we all got involved looking for “zero.” DuPont tried to lead the way in the slogan department. “Our goal is zero – zero accidents, zero wastes, zero emissions, and zero excuses!” I loved the last part. Despite all of the whoopla, DuPont and a lot of other companies are still searching for zero. This despite that the zero advocates set the null point as something “north of zero.” Consider six sigma, which some people referred to as zero waste. This term represents 3.4 defects per million operations. If you are a scientist, this is not zero. If you are an engineer, it is darn close. Continue reading
#198 – DECISIONS OR INDECISIONS – IT’S A LEADERSHIP THING! – MALCOLM PEART
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Question: Decisions, why do we need them?
Answer: To know what to do; when, where and how to do it; and by who.
But who makes them? Everybody makes decisions everyday, all the time, about what to eat, what to do at the weekend, and decisions regarding work. Work decisions are made at all levels of an organisation and can influence time, cost, and quality and may contribute to failure or success. Continue reading
#198 – FIVE PRIMARY REASONS FOR THE FAILURE OF PREDICTIVE ANALYTICS IN ERM – GREG CARROLL
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Regardless of the hype surrounding Predictive Analytics, and even the fact there are some excellent and relatively inexpensive tools available, not only has its implementation been weak, but a 2017 Gartner survey found in many areas investment is going backwards. Continue reading

